New Pattern of Retinal Laser Treatment for PDR
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEye & ENT Hospital of Fudan University
About this trial
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Having given free and informed consent to take part in the study.
Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.
Disqualifiers
Previous treatment with PRP;
Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
Trial design
Design model
Single group
Treatments tested in this trial
A new pattern of retinal laser
Procedure/SurgeryA new pattern of retinal argon laser combines anti VEGF treatment within 2 weeks. Spot argon-laser photocoagulation was started 1 disc-diameter nasal to the optic disc, outside the superior and inferior vascular arcades, and 2 disc diameter (DD) temporal to the fovea, and the mid-peripheral retina flanking the large vessels. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Retinal laserExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
BCVA
BCVA stands for best-corrected visual acuity, measured by Snellen chart.
Time frame
From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)2
CMT
CMT stands for central macular thickness, measured with optical coherence tomography (OCT) images, which serves as one of the key indicators of DR progression.
Time frame
From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)3
Mean VF loss
VF stands for visual field. Mean deviation would be used to evaluate the VF loss.
Time frame
1 year and 2 years after the initial laser treatment during the follow-up period.4
Further treatment
Number of participants with further laser treatment, anti-VEGF treatment or vitrectomy.
Time frame
From enrollment to the end of the 2-year follow-up period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: